AstraZeneca
Clinical Research Associate
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Clinical Research Associate
Job Title: Clinical Research Associate
Location: UK - Field-based
Introduction to Role
As a Clinical Research Associate, you will be the primary face of our studies at assigned sites, ensuring excellence from start-up through close-out. You will collaborate closely with local study leadership and cross-functional partners to uphold the highest standards of quality, compliance, and patient safety. Your work will directly influence trial timelines, data integrity, and the speed at which new therapies move forward.
In this role, you will bring structure and momentum to complex studies by training and guiding site teams, leveraging risk-based approaches, and translating insights from the field into action. You will join a community that pairs scientific rigor with digital and data-driven tools, all in service of delivering life-changing medicines to people who need them most.
Accountabilities
- Identify and Assess Investigators:
- Contribute to identifying and assessing potential investigators to build a high-performing site network aligned with protocol needs and patient access.
- Site Start-Up and Regulatory Maintenance:
- Lead start-up and regulatory maintenance including Site Qualification Visits; collection, preparation, review, and tracking of documents; and submissions to EC/IRB and Regulatory Authorities for study start-up and throughout the study.
- Training and Support:
- Train, support, and advise Investigators and site staff on study-specific requirements and Risk Based Quality Management principles; confirm completion and documentation of required training, including ICH-GCP; keep sites inspection-ready at all times.
- Actively participate in Local Study Team meetings and contribute to National Investigators meetings as applicable; share recruitment and site performance insights to drive data-informed decisions and actions.
- Study Monitoring:
- Initiate, monitor, and close study sites in line with AstraZeneca Procedural Documents and the study-specific Monitoring Plan; perform remote and onsite visits and remote data checks; collaborate with LSAD on visit timing and type when required.
- Perform Source Data Review, Case Report Form review, and Source Data Verification per the Monitoring Plan; conduct regular Site Quality Risk Assessments and adapt monitoring intensity accordingly; ensure timely data query resolution and partner with data management to drive robust data quality.
- Adverse Events and Compliance:
- Ensure accurate and timely reporting of Serious Adverse Events and follow-ups; escalate systematic or serious quality issues, data privacy breaches, and CSP or ICH-GCP compliance issues per local processes; ensure compliance with the Code of Ethics, company policies (including SHE) and local/national/regional legislation.
- Study Supplies Management:
- Manage study supplies, drug supplies, and drug accountability at sites; prepare study drug for destruction where applicable.
- Documentation and Reporting:
- Update CTMS and other systems within required timelines; prepare and finalize monitoring visit reports and follow-up letters in line with SOPs; ensure timely collection and upload of essential documents into the eTMF and support regular QC checks; ensure site documents and communications are ready for archiving and completion of the local eTMF.
- Audits and Inspections:
- Prepare for and collaborate during audits and regulatory inspections with LSAD and CQAD; assist sites in maintaining an inspection-ready ISF.
- Feedback and Collaboration:
- Provide feedback on research-related information including site and investigator insights and competing studies; collaborate with local MSLs as directed by LSAD or line manager.
- Site Performance:
- Drive site performance by proactively identifying issues, resolving them promptly, and escalating appropriately; with tenure and experience, take on additional responsibilities associated with LSAD to broaden your impact.
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Essential Skills/Experience
- Bachelor's degree in a related discipline, preferably in life science, or equivalent qualification.
- Excellent knowledge of international guidelines ICH-GCP.
- Good knowledge of relevant local regulations.
- Good knowledge and experience of cell and gene therapies.
- Understanding of the drug development process.
- Prior experience in monitoring clinical trials in late phases (2-4), study drug handling, and data management.
- Excellent attention to detail.
- Good written and verbal communication skills.
- Good collaboration and interpersonal skills.
- Good negotiation skills.
- Ability to travel nationally/internationally as required.
Desirable Skills/Experience
- Ability to work in an environment of remote collaborators.
- Manages change with a positive approach for self, team, and the business; sees change as an opportunity to improve performance and add value.
- Ability to champion more efficient and effective methods and processes to deliver quality clinical trials with reduced budget and in less time.
- Good analytical and problem-solving skills.
- Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
- Familiarity with risk-based monitoring approaches, including remote monitoring.
What is Next?
Take the next step and turn your monitoring expertise into real-world patient impact. Join us to deliver smarter, faster trials. We look forward to receiving your application not later than 12th July 2026.
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Dates
- Date Posted: 03-Jul-2026
- Closing Date: 12-Jul-2026
Our Mission
Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.
About AstraZeneca
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing, and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention, and unleash your entrepreneurial spirit.
To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth, and development for all.
Inclusion & Diversity (I&D) Mission
Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking.
We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab.
Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day.
This is your life at AstraZeneca.
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